Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 6)
Section 11 (m) of RA 3720 as amended prohibits the release for sale or distribution of antibiotic drugs without Batch Certification, ensuring their quality and safety before market release.
An antibiotic drug is defined as any drug intended for human use that contains any quantity of a chemical substance produced by microorganisms capable of inhibiting or destroying microorganisms in dilute solution, including chemically synthesized equivalents of such substances.
No, quinolone derivatives such as ciprofloxacin, difloxacin, enoxacin, fleroxacin, nalidixic acid, norfloxacin, ofloxacin, perfloxacin, and sparfloxacin are excluded from BFAD batch certification requirements.
Veterinary antibiotic products are excluded from the BFAD batch certification requirement as they do not fall under the definition of antibiotic drugs that require certification under Section 22 (a) of RA 3720.
BFAD stopped issuing batch certifications for quinolone derivatives and veterinary antibiotic products effective September 15, 1996.
The circular was adopted on October 1, 1996, but the exclusion took effect on September 15, 1996.
Because they do not fall squarely within the statutory definition of antibiotic drugs under RA 3720 Section 22 (a), the BFAD determined that these products do not require batch certification.
BFAD batch certification serves as a regulatory measure ensuring that antibiotic drugs meet quality standards before being released for sale or distribution.
While quinolone derivatives are excluded from batch certification, they remain subject to other regulatory controls to ensure their safety and efficacy.